|Iber Biotech Stock Notes||
News, Feb 8, 2013.
- Pozen presents positive Phase III data at stroke conference.
- GSK files MAA with EMA for trametinib as monotherapy and in combo with dabrafenib for metastatic melanoma.
- Addex Therapeutics to refocus pipeline, structure Geneva operations.
- Germany's Federal Joint Committee says Vertex's Kalydeco provides significant benefit.
- Acceleron's eight Phase II trials.
- Lilly discontinues tabalumab for rheumatoid arthritis.
- €196 M pan-European drug discovery platform launched.
- Elan, Biogen Idec ink $3.25 B deal for MS drug Tysabri.
News, Jan 31, 2013
- Celsion Phase III HEAT study fails.
- FDA to hold a public hearing on ALS on Feb 25.
- Genzyme/ISIS' Kinamro to be priced at $176,000/year.
- Pharmaxis' Bronchitol gets negative vote from FDA advisory committee.
- VC Edmond de Rothschild to raise $500 M over four years.
- Antibody company KaloBios preparing for IPO.
- Stemline jumps 18% on its first day of trading.
News, Oct 3 2012 .
- Sarepta presents 48 week data in Duchenne Muscular Dystrophy.
- Arqule drops 55% on Phase III MARQUEE trial discontinuation.
- Sanofi Gaucher's therapy meets Phase III endpoints.
- J&J and Astellas strike a deal for JAK inhibitor RA drug.
- Merck Serono spins out newco to develop AD assets.
- US Dept. of Defense to continue funding Tekmira's Ebola program.
- Ablynx and Merck in Nanobodies deal for up to $590M.
- Antabio closes seed round of crowdfunding: €300k /200 investors.
News, July 20 2012.
- Durata raises $67.5M in IPO .
- Actelion up 5.7% after raising guidance.
- BB Biotech aims for 10% annual return.
- Stemline Therapeutics sets IPO range, to raise a maximum of $50M
- Genzyme-marketed test sees positive results.
- EMA to publish meetings agendas and minutes.
News update, May 24 2012
- FDA Panel recommends against J&J's Xarelto for ACS
- Celldex reports data for CDX-011.
- Medicinova's Phase II trial fails in patients with acute asthma attacks
- European Medicines Agency will review Takeda's alogliptin
- EMA to review Gilead's cobicistat
- Patient Centered Outcomes Research Institute to award $120M
- David Blech admits illegally trading stock for 2nd time (Intelect, Pluristem)
News, April 2
- Full roster of Exelixis' cabozantinib data presentations expected at ASCO 2012.
- Vectura Group PLC : QVA149 phase III COPD studies met primary endpoints.
- Morphosys will start share buyback program.
News, Mar 27
- MAP Pharmaceuticals' Levadex rejected by the FDA.
- Bausch and Lomb to acquire Ista for $500M.
- FDA to obesity panel: assume preapproval CV trial required.
- Xarelto non-inferior to standard therapy in venous thromboembolism.
- Amgen and Regeneron report positive data of their PCSK9 mAbs.
- Merck invests $50M in Lumira funds.
- Privaty equity firm Celtic launches ADC Therapeutics.
News, Mar 23
- Glaxo and Theravance announce topline results from Relovair vs. Advair Phase 3 studies in COPD.
- Clovis announces public offering.
- Addex jumps 84% on Phase IIa data for PD-LID therapy .
- FDA AdCom to review Repligen's secreflo on May 31.
- Pozen rises on Phase III cardiovascular data.
- Synthon's biosimilar trastuzumab bioequivalent to Herceptin.
- Novartis and Walgreens team up to conduct clinical trials.
- Abbot names its new spin-off Abbvie.
News, Feb 9 2012
-The 25 most influential people in biopharma today (via Fierce Biotech).
- FDA ODAC panel votes 12-1 against Amgen's Xgeva.
- Chemocentryx goes public (NASDAQ: CCXI).
- Anacor raises $21.5M in follow-on.
- Sanofi reports financial results: expects decline in EPS and updates pipeline.
- Exelixis presents financial results. See PR and Earnings call transcript.
- Basilea Pharmaceutica presents results. (See my stock note here)
- Forest and Gedeon Richter reports results from phase III of antipsychotic drug.
- Array, Apricus and Ironwood are planning follow-ons.
- FDA committee to discuss Astellas' OAB product.
News, Jan 20, 2012.
- 4SC (Xetra:VSC) surges 40% on resminostat data in HCC.
- Clovis announces FDA's IND acceptance for Oral EGFR Mutant-Selective Inhibitor CO-1686.
- BMS and AstraZeneca experience yet another pipeline setback.
- Ziopharm and Sequenom offering.
- UK's Incanthera raises $0.5M to get its anticancer compound into clinical trials.
- EMA's CHMP releases draft on biosimilars for interferon beta.
- Europe Drugmakers May Boost Acquisitions After Buyback Focus.
Top 10 biotech gainers and losers in 2011, Jan 6, 2012.
Click here to see Biopharma stocks with the biggest percentage gain or loss in the US and Europe, above $1 or equivalent.
Latest News, Jan 5, 2012
- Basilea Pharmaceutica to file MAA for ceftobiprole plus Phase III data for aletritoin coming up soon. (See stock note here)
- Positive preliminary results from Alnylam's Phase I ALN-PCS trial on severe hypercholesterolemia.
- COPD play Elevation raises $30M in series B to continue development of its nebulized LAMA.
- Biogen Idec and Isis strike deal on antisense drug.
- Amarin down 10% after pricing $150M note deal.
- Synageva planning follow-on and rare disease drug data release by next month.
- Scientists say unreported drug data a health hazard.
News. Dec 22, 2011
- Curis Announces Roche's Submission of MAA for Vismodegib in Advanced Basal Cell Carcinoma.
- Exelixis inks $257M deal with Merck.
- Vivus reports FORTRESS data.
- Progenics, Salix gain on constipation data.
- AstraZeneca pacts to enhance cancer and diabetes pipeline.
- Merck ends AD deal with Acumen.
- EMA to review Lunbeck's Selincro for alcohol dependance.
- EMA to review Gilead's Quad.
- Repligen submits SecreFlo NDA.
- FDA to review Pfizer's JAK3 inhibitor tofacitinib for RA.
- FDA approves Takeda's azilsartan/chlorthalidone for hypertension .
NEW STOCK NOTE: BASILEA PHARMACEUTICA, December 15, 2011
News Dec 13, 2011.
- Panel vote tips in Alexza's favor.
- European Commission approves Optimer/Astella's Dificlir.
- FDA approves crush-resistant formulation of Endo's Opana.
- News from the American Society of Hematology meeting 2011.
- YM BioSciences Reports Updated Phase I/II Data for its JAK1/JAK2 Inhibitor CYT387.
- Ariad Pharmaceuticals reports positive data from its leukemia drug.
- Incyte's Jakafi discussed at multiple presentations at ASH.
- Onyx Pharmaceuticals Presents Carfilzomib Data at 53rd ASH meeting.
- Pharmacyclics Reports Interim Phase II Trial Results for BTK Inhibitor 32765 in MCL.
- Ligand Announces Positive Preclinical Data on Small-Molecule GCSF Receptor Agonist
Latest news. Dec 7-9, 2011
- Pearl's PT001 meets COPD endpoint
- Surge in Lilly shares highlights perils, potential of Alzheimer's drugs
- Alexza gets hammered as reviewers identify Adasuve safety concerns .
- Exelixis’ Cabozantinib Shows Encouraging Clinical Activity in Patients With Metastatic Breast Cancer
- Zealand Pharma's Lyxumia meets GetGoal-M.
- Pharmacyclics and Johnson & Johnson strike cancer deal.
- Forbion unveils $50M fund for lightning round of late-stage investments
- Janssen inks $800M discovery deal for Molecular Partners' small protein tech
- EMBL Ventures closes second €40m life sciences fund
News. Nov 28-29, 2011
Cytokinetics Announces Opening of Third Phase II Clinical Trial of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis.
Novartis and Vectura file for approval of NVA237 in Japan (Vectura analysis here)
Global Fund cancels funding round in Tuberculosis, Malaria and AIDS.
AstraZeneca adds $100M to VC arm MedImmune Ventures.
EC approves Gilead's Eviplera
Infectious Diseases co. Rib-X seeks going public
Exelixis Signs CRADA With National Cancer Institute to Expand Development Plan of Cabozantinib
Pfizer buys Excaliard
NICE rebuffs Lucentis in macular edema
New update! Analysis on COPD company Vectura. Nov 24, 2011.
News. Friday, Nov 18 2011
FDA GI panel: CV safety studies unnecessary for serotonin (5-HT4) receptor agonists in GI Agios' $78m venture round
Europe's Oxyrane raises $26.5M in a series D and Biocartis raises €71 million
European Commission wants faster approval of new antibiotics
Priority Review for Chelsea's Northera
EMA to review Avanir's Nuedexta
Web update!! Note on Incyte Pharmaceuticals Breaking news: Incyte gets approval!! (11:03hs ET Nov 16)
Latest news. Tuesday, Nov 15 2011
Geron abandons stem cell development. Down 17% in after-hours trading.
Exelixis Reveals Positive Data From Phase 2 Study Of Cancer Drug Cabozantinib
Salix falls as FDA on briefing docs for Xifaxan panel
Dyax withdraws Kalbitor MAA on CHMP comment.
Big profits spur questions about Siga's $433M drug contract - FierceBiotech
News for Friday Nov 11, 2011
Alimera tanks 76% on FDA request for two more Iluvien trials
FDA, EMA to review Astellas' mirabegron
Senate to consider new FDA approval paths
Otsuka, Lundbeck in psychiatric deal
Latest News. Thursday, Nov 10 2011
Watson/Columbia Say Progesterone Gel NDA To Be Reviewed By FDA Panel On Jan. 20
Regeneron/Sanofi's Anti-PCSK9 mAb meets hypercholesterolemia endpoints
Ablynx Reports Phase II Data for ALX-0081 in High Risk Acute Coronary Syndrome in Patients Undergoing a PCI Procedure. It misses in ACS, it continues in TTP
Daiichi exercises option for ArQule cancer product ARQ 092
GlaxoSmithKline launches $50M Canadian fund
Web update! Stock note on Exelixis
News Monday Nov 7, 2011
Canakinumab meets juvenile arthritis endpoints. $NVS
More on HCV developments: Santaris presents miravirsen Phase IIa HCV data and Phase IIb SVR data for Pharmasset's PSI-7977. $VRUS
J&J's sirukumab meets Phase II endpoint in active rheumatoid arthritis
Web update! Stock Note: update on Cytokinetics
News mix from Friday Nov 4, 2011
Ablynx off 18% on Pfizer deal termination
FDA approves Xarelto for atrial fibrillation, label issues linger.
HCV companies in the spotlight: Pharmasset and BMS expand Phase IIa HCV trial. Inhibitex soars more than 100% on Phase I data
OxiGene and Rexhan plunged 33% on clinical trials data.
Web update! Stock Note on Ariad Pharmaceuticals
There we go!
Nov 7 , 2011
Welcome all to this new website that I’m launching today. It’s an exciting project to have my own forum where I can express my views and comment on biotech stocks as well as other emerging technologies in the life sciences space. Tour the website and visit the different sections to get an idea on what it might offer you. I expect to have everything updated and running at full steam asap. Enjoy!
Transition to Chimera Research Group.
I'm excited to join a team of superb professional biopharma analysts as a contributor for the next year. My analyses and brief notes on selected stocks will be published there from now on. Subscribe to Chimera Research Group here